The present invention relates to sterile packaging of medical equipment, and in particular to a device for the simplification of manual handling of parts which must be sterile when placed in contact with an area on the body of a patient, for example, a puncture site or the like.
The invention is especially suitable for use with inflatable cushions which are used for femoral compression by means of a femoral compressor as described in Swedish patent application nos. 9002077-7 and 9003271-5, which are herein incorporated by reference.
In Swedish patent application nos. 9002077-7 and 9003271-5 the femoral compressor is supplied as one unit (arch and air cushion) in a sterile package which is opened just prior to application onto the patient. The disadvantage with this construction is that the manufacturing and transport costs are high, and that the waste, i.e. the entire unit, is bulky. For possible reuse, the entire compressor must be resterilized, in e.g. an autoclave, in which case the device's large volume is a disadvantage.
The greatest disadvantage with the femoral compressors of the cited application is that there is a risk that the contact surface of the permanently mounted air cushion may be contaminated between the time that the sterile compressor is removed from the package and when it is applied, e.g. on the bleeding puncture site.
In addition, the blood contamination of the compressor must be treated as hazardous waste, resulting in troublesome handling of the bulky unit.
In an alternative form of the compression unit of Swedish patent application nos. 9002077-7 and 9003271-5, the air cushion is a separate part and is mounted on a base plate 7 which is attached to the arch 2 by means of e.g. double adhesive tape.
Even in this case, there is a risk of contaminating the air cushion when attaching it to the arch, since the sterile packaging enclosing the cushion and its base plate must be opened before the cushion is mounted manually onto the arch.
In general, sterile, single-use items which are used in health care and especially during surgical procedures, are usually packaged in sealed, gas-permeable pouches (e.g. TYVEK, a du Pont trademark), so that they can be gas sterilized using ethylene oxide gas after the pouches have been sealed. Sterilization of the sealed item can also be done by means of radiation treatment (electron radiation, that is, beta sterilization or gamma radiation). A disadvantage with this kind of sterile packaging is that when the part is to be used, it must be removed from the pouch and handled manually, which clearly implies a risk of contamination of the part on the way to the patient, even if the distance is not very great.
Therefore, there is a need to be able to handle a sterile part in a safe way, so that the risk for contamination is reduced as much as possible. This can be done by using a package which is constructed in such a way that the seal need not be broken until just before the part is placed on the patient. In this way, the part, e.g. an air cushion for a femoral compressor, can be handled manually and positioned on the patient with no particular care being necessary to avoid contamination.